The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.

Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)

Other Name: Ketek

Drug: Azithromycin

Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)

Eligibility

Ages Eligible for Study:

18 Years to 35 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrollment into the study:

Male and female adult outpatient subjects diagnosed with AECB or CAP

Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control.

Informed consent must be obtained in writing for all subjects upon enrollment.

Subjects will have a diagnosis of AECB or CAP, as defined below.

AECB-Specific Inclusion Criteria:

Subjects greater than or equal to 35 years of age

Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70%.

Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume

Subjects with current acute respiratory failure or subjects who require aggressive airway management

Hospitalized subjects and subjects from institutional care facilities

Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period

Subjects who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety

Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult

Subjects with a progressively fatal disease or life expectancy of < 3 months

Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period

Subjects with a recent (within 3 months) history of drug or alcohol abuse

Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count < 200/mm3); known neutropenia (< 1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia.

Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study

Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study)

Subjects who have known impaired hepatic function

Subjects who have known impaired renal function

AECB-Specific Exclusion Criteria:

Subjects with acute bronchitis

Subjects with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; or active pulmonary tuberculosis.

The investigator and sponsor must approve any waiver of these inclusion and exclusion criteria on a case-by-case basis prior to enrolling a subject. Both the investigator and sponsor must document any waivers.

No subject will be allowed to enroll in this study more than once.

Subjects of Reproductive Potential:

Women of childbearing potential may participate in the study only if the following conditions are met:

Had a normal menstrual flow ≤ 1 month before study entry

Has a negative pregnancy test (serum β-subunit hCG) immediately before study entry (ie, before the start of treatment or any other study procedure that could potentially harm the fetus). If obtaining the serum pregnancy test result will cause a delay in treatment, a subject may be entered on the basis of a negative urine pregnancy test sensitive to at least 50 mU/mL, pending results of the serum pregnancy test. Subsequently, if the result of the serum test is positive, the subject must be discontinued from study drug, and every attempt must be made to follow such subjects to term.

Must agree to use an accepted method of contraception (ie, oral or implanted contraceptive with a barrier method; spermicide and barrier methods; or intrauterine device). The subject must agree to continue with the same method throughout the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132951